Overview

Participants will have the opportunity to interact with regulators including WHO, DCG(I), Indian MoH and Members of European Federation of Pharmaceutical Industries and Associations (EFPIA India Regulatory Network) and the Organisation of Pharmaceutical Producers of India (OPPI) on key regulatory topics including Orphan drug regulation, Clinical trial waiver, Accelerated regulatory pathway and Biological product/ Biosimilars registration in India.

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Who should attend?

WHO SHOULD ATTEND

Regulatory Affairs professionals
Assessors in regulatory authorities

Learning objectives

This workshop aims to bring together regulators and implementers to exchange viewpoints on key regulatory topics including Orphan drug regulation, Clinical trial waiver, Accelerated regulatory pathways and Biological product/Biosimilars registration in India.

Program Committee

Shekhar Natarajan Head-International Regulatory Strategy
Shire, United Kingdom, United Kingdom
Bente Brunbakke Regional Manager-Gulf, India and Egypt,
Novo Nordisk A/S, Denmark
Nagaraj Bannur Head-Regulatory Affairs and Patient Safety, India and Subcontinent
AstraZeneca Pharma India Limited, India
Finny Liu, MSc, RPh APAC Regional Regulatory Policy Lead
Roche, Singapore
Kum Cheun Wong, PharmD Head Asia Pacific Regulatory & Development Policy
Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
Thean Soo Lo
Regulatory Affairs Management Consultant, Singapore

Digital Learning Catalog

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EFPIA DIA OPPI Regulatory Workshop

Overview

Who should attend?

Learning objectives

Program Committee

Digital Learning Catalog

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